(Reuters) -The U.S. Food and Drug Administration is probing the death of a patient who developed harmful antibodies after taking Takeda Pharmaceuticals' blood disorder therapy, the health regulator said on Friday.
The pediatric patient died about 10 months after starting Takeda's drug Adzynma as a preventive therapy, the agency said.
The child had congenital thrombotic thrombocytopenic purpura (cTTP), an inherited condition that causes blood clots in small vessels and can lead to organ damage.
The FDA said the child developed antibodies that blocked the activity of ADAMTS13, an enzyme critical for blood clotting.
Takeda did not immediately respond to Reuters request for comment.
Adzynma, approved in 2023 as the first therapy for cTTP, replaces the ADAMTS13 protein to help prevent dangerous blood clots.
The agency added it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13 after treatment with Adzynma.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
LATEST POSTS
- 1
Israel reports second missile fire from Yemen since start of Iran war - 2Hamas hands over another body in the Gaza Strip
- 3Defense Minister Katz moves to extend IDF service to 36 months
- 4The most effective method to Look at Medical caretaker Compensations Across Various Clinics
- 5Which Switch Game Do You Suggest? Share Your Decision
- 10 Demonstrated Tips to Expand Your New Android Cell phone: A Thorough Aide
- Study finds humans were making fire 400,000 years ago, far earlier than once thought
- A definitive Manual for Internet Mastering and Expertise Improvement
- UNICEF: More than 100 children killed in Gaza since ceasefire
- Top Frozen yogurt Flavor: Cast Your Vote!
- Physicists and philosophers have long struggled to understand the nature of time: Here's why
- 'We need everyone,' wounded reservist urges Knesset panel to advance haredi draft law
- IDF strikes Tehran command centers, weapon production sites
- Ukraine to get up to 100 French-made Rafale fighter jets
